The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2025 (PDF).
This issue advises healthcare professionals that review by two specialists remains in place for patients initiating valproate under 55 years of age but the Commission on Human Medicines (CHM) has advised that it will not be required for men (or males) currently taking valproate. To aid the decision making process for initiation and review, three infographics have been produced, for female patients under 55 years old, for male patients under 55 years old and for male and female patients 55 years and older. Patients are recommended to continue taking valproate until reviewed by their specialist.
Lastly, this issue contains a summary of letters to healthcare professionals in January. These generally related to supply issues and recalls.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of February 2025. This month there is one guideline that impacts upon primary care.
The Tobacco: preventing uptake, promoting quitting and treating dependence guideline has been updated. It covers support to stop smoking for everyone aged 12 and over, and help to reduce people's harm from smoking if they are not ready to stop in one go. It also covers ways to prevent children, young people and young adults aged 24 and under from taking up smoking. This update reviewed the evidence for cytisinicline (sometimes referred to as cytisine) and made new and updated recommendations in the section on stop-smoking interventions.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Faculty of Sexual and Reproductive Health (FSRH) has published a clinical statement advising that individuals use contraception whilst using GLP-1 agonists. There is also additional advice for individuals using tirzepatide.
The statement notes that there is a lack of safety evidence for this group of drugs in pregnancy and as such contraception should be used during treatment with all GLP-1 agonists. Details of the 'washout' period should also be shared if pregnancy is planned, the time period before ending treatment and when the medication is cleared fully from the body.
Within this class of medicines, tirzepatide is the only drug that has been found to have a clinically significant effect on the bioavailability of oral contraceptives. It is advised that consideration be given to switching to a non-oral methods of contraception, or adding a barrier method of contraception for four weeks after initiation and for four weeks after each dose increase.
Finally within this statement, it is recommended that individuals who experience severe diarrhoea or vomiting during use of GLP-1 agonists should follow existing recommendations with respect to maintaining effect contraception.
Action: Clinicians who commence or review patients using GLP-1 agonists should be aware of these recommendations and ensure that patients are suitably advised and offered appropriate contraception where necessary.
Thanks to Rita Shah for spotting this article.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Netarsudil / latanoprost (Roclanda®) has been accepted for restricted use in the treatment of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction. The restriction limits use to patients for whom treatment with a prostaglandin analogue alone provides insufficient IOP reduction, only if:
- the patient has then tried a fixed-dose combination treatment and it has not sufficiently reduced IOP, or
- a fixed-dose combination treatment containing beta-blockers is unsuitable
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During January 2025 Clinical Knowledge Summaries were published or updated in the following areas.
The Cushing's syndrome topic is new. All of the topics have been reviewed and updated with minor structural and layout changes. The Asthma topic has been updated in line with the joint BTS/NICE/SIGN guideline including recommendations on objective testing during diagnosis and management with AIR therapy or MART. The Hyperthyroidism and Hypothyroidism topics have both been updated in line with the NICE clinical guideline Thyroid disease: assessment and management. The Incontinence - urinary, in women topic has been restructured and now includes vibegron as a treatment option in accordance with the NICE technology appraisal.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
